PMID- 2274889 OWN - NLM STAT- MEDLINE DCOM- 19910228 LR - 20121115 IS - 0040-3709 (Print) IS - 0040-3709 (Linking) VI - 42 IP - 3 DP - 1990 Sep TI - Developmental toxicity of temafloxacin hydrochloride in the long-tailed macaque (Macaca fascicularis). PG - 233-42 AB - The potential developmental toxicity of temafloxacin hydrochloride was studied in the long-tailed macaque (Macaca fascicularis). Ten animals in each of the three drug-treated groups (25, 50, and 100 mg/kg) were administered temafloxacin via nasogastric intubation during gestational days (GD) 20-50. A control group of ten animals received vehicle only. The dams were monitored daily for adverse physical signs and maternal blood samples were collected for analyses of serum progesterone (P), 17 beta-estradiol (E2), and chorionic gonadotropin (CG). In addition, the conceptus was monitored periodically by ultrasound during gestation to confirm growth and viability. Increased maternal toxicity (weight loss, anorexia, emesis) and embryolethality were observed at 100 mg/kg, and a no-observable-adverse-effect-level (NOAEL) of 50 mg/kg was established. The incidence of prenatal mortality was as follows: Control = 1/10 (10%); 25 mg/kg = 1/10 (10%); 50 mg/kg = 2/10 (20%); and 100 mg/kg = 5/10 (50%). Analysis of P, E2, and CG indicated no significant effect of treatment. In addition, no significant differences were observed in embryonic/fetal growth and development when compared to historical controls. No gross structural changes were observed in fetuses exposed to 50 or 100 mg/kg, although one fetus exposed to 25 mg/kg exhibited microphthalmia. This anomaly was considered spontaneous and, therefore, unrelated to treatment. FAU - Tarantal, A F AU - Tarantal AF AD - California Primate Research Center, University of California, Davis 95617-8542. FAU - Lehrer, S B AU - Lehrer SB FAU - Lasley, B L AU - Lasley BL FAU - Hendrickx, A G AU - Hendrickx AG LA - eng PT - Journal Article PL - United States TA - Teratology JT - Teratology JID - 0153257 RN - 0 (4-Quinolones) RN - 0 (Anti-Infective Agents) RN - 0 (Fluoroquinolones) RN - 0 (Quinolones) RN - 0 (Teratogens) RN - 1WZ12GTT67 (temafloxacin) SB - IM MH - 4-Quinolones MH - Animals MH - Anti-Infective Agents/*toxicity MH - Appetite/drug effects MH - Dose-Response Relationship, Drug MH - Embryonic and Fetal Development/*drug effects MH - Female MH - *Fluoroquinolones MH - Macaca fascicularis MH - Pregnancy MH - *Quinolones MH - *Teratogens MH - Vomiting/chemically induced EDAT- 1990/09/01 00:00 MHDA- 1990/09/01 00:01 CRDT- 1990/09/01 00:00 PHST- 1990/09/01 00:00 [pubmed] PHST- 1990/09/01 00:01 [medline] PHST- 1990/09/01 00:00 [entrez] AID - 10.1002/tera.1420420307 [doi] PST - ppublish SO - Teratology. 1990 Sep;42(3):233-42. doi: 10.1002/tera.1420420307.